Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy
Completed · Not applicable
Conditions studied: Obesity, Obesity, Morbid, Obesity; Endocrine, Bariatric Surgery Candidate
In brief
Rapid metabolic improvements seen with sleeve gastrectomy are likely a result of changes in gastric origin. The gastric mucosa is an endocrine organ that regulates satiation pathways and is a complex regulator of food intake as well as lipid and glucose metabolism. This study aims to assess the efficacy and safety of endoscopic selective gastric mucosal devitalization (GMD) for the management of obesity and its related comorbidities.
Key facts
- Study ID
- NCT03526263
- Run by
- Johns Hopkins University
- People needed
- 6
- Starts
- 2018-06-07
- Expected to finish
- 2018-11-29
- Last updated by the study team
- 2019-09-24
Who can join
Age: 28 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients scheduled to undergo vertical sleeve gastrectomy
You may not qualify if…
- Age under 28 or older than 60
- Insulin dependent Diabetes Mellitus
- Suspected or biopsy confirmed liver cirrhosis
- Significant ethanol consumption >21 drinks/week in men and >14 drinks/week in women
- Presence of other chronic liver disease including hepatitis B-C, autoimmune hepatitis, alpha 1 antitrypsin deficiency, Wilson's disease, and hemochromatosis
- Pregnant or breast-feeding
- Patients who already have an intragastric balloon or other gastric implant
- Patients with gastroesophageal reflux disease
- Patients with previous gastric surgeries, altered gastrointestinal anatomy such as Billroth I, Billroth II, roux-en-y gastrectomy, roux-en-y hepaticojejunostomy, or any restrictive or bypass bariatric surgery
- Patients with previous gastric embolization for obesity
- Presence of inflammatory disorder of the gastrointestinal tract
- Patients with active peptic ulcer disease
- Patients with gastroesophageal varices
- Presence of a large hiatal hernia (grade IV on Hills classification: large hiatal hernia and essentially no fold approximating the endoscope in the retroflexed view and where the lumen of the esophagus is gaping open allowing the squamous epithelium to be seen)
- Structural abnormality in the esophagus or pharynx
- Have major esophageal motility disorders as per the Chicago classification including achalasia, diffuse esophageal spasm, jackhammer esophagus, and Esophagogastric junction outflow obstruction
- Mucosal or submucosal gastric mass that is clinically suspected to be of malignant nature
- Severe clotting or bleeding disorder
- Other medical condition that does not allow for endoscopic procedure
- Severe psychiatric illness
- Unable to participate in routine medical follow-up
- On antiplatelet agents including clopidogrel, ticlopidine, prasugrel, and cangrelor. acetylsalicylic acid use will be allowed
- On anticoagulants including heparin, warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban
Where it is running
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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